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Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures (PROGAINT-ES)

This study has been completed.
Sponsor:
Collaborator:
Synthes Inc.
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00736684
First received: August 15, 2008
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).


Condition Intervention Phase
Unstable Trochanteric Fractures
 Device: Proximal Femoral Nail AntirotationTM (PFNA)
Device: Gamma Nail 3TM (Gamma3)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Any fracture fixation complication. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Proximal Femoral Nail AntirotationTM (PFNA)
 Device: Proximal Femoral Nail AntirotationTM (PFNA)
intramedullary nailing
2
Gamma Nail 3TM (Gamma3)
 Device: Gamma Nail 3TM (Gamma3)
intramedullary nailing

Detailed Description:

Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 55 years and more
  • Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
  • Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
  • Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups

Exclusion Criteria:

  • Pathologic fracture of any other cause than osteoporosis
  • Patients or legal guardian refusing to sign the informed consent form
  • Multiple trauma
  • Type 2 and 3 open fractures
  • Drug or alcohol abuse
  • Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
  • Active malignancy
  • Expected life expectancy ≤ 3 months
  • Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects)
  • Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
  • Rheumatoid arthritis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736684

Locations
Spain
Hospital Universitario "Marqués de Valdecilla"
Santander, Cantabria, Spain, 39008
Hospital Clinic
Barcelona, Cataluña, Spain, 08036
Hospital Puerta de Hierro
Madrid, Spain, 28035
Hospital Gregorio Marañon
Madrid, Spain, 28007
H.U. Virgen de la Arrixaca
Murcia, Spain, 30071
Hospital Donostia
San Sebastián, Spain, 20014
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
Investigators
Study Director: Beate P. Hanson, MD AO Clinical Investigation and Documentation, Davos, Switzerland
Principal Investigator: Javier Vaquero Martin, MD Hospital Gregorio Marañon, Madrid, Spain
  More Information

No publications provided

Responsible Party: Javier Vaquero Martin, MD, Hospital Gregorio Marañon
ClinicalTrials.gov Identifier: NCT00736684     History of Changes
Other Study ID Numbers: PROGAINT-ES-08
Study First Received: August 15, 2008
Last Updated: February 10, 2011
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by AO Clinical Investigation and Documentation:
Femoral fractures [MeSH]
hip fractures [MeSH]
trochanteric fractures (femoral neck fractures [MeSH])
intramedullary nailing (fracture fixation, intramedullary [MeSH])
 complex femoral fractures
femoral nail
surgical treatment (surgical procedures, operative [MeSH])
complications

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 21, 2013